MAPT Protocol: Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP)

The Musculoskeletal Adaptive Platform Trial (MAPT) is an adaptive platform trial protocol that enables the simultaneous evaluation of multiple interventions (i.e., intervention domains) within a consistent infrastructure. Each intervention being evaluated in the MAPT will have an intervention domain protocol that describes additional eligibility criteria, interventions, secondary outcomes, and statistical stopping rules. The overarching objective of the MAPT trial platform is to incrementally decrease decisional uncertainty and identify treatments that will optimize patient outcomes. The platform focuses on the comparative effectiveness of available treatment options.

Adult patients aged 60 years or older with a low-energy minimally displaced femoral neck fracture treated with surgery are eligible for the FASTER-HIP intervention domain. Nearly half of all elderly hip fractures are femoral neck fractures, and approximately 20% are minimally displaced. Internal fixation has remained the treatment of choice for these injuries because these fractures can be fixed in situ, and the surgical implants can be inserted with little surgical dissection. Patients treated with internal fixation experience high complication rates, with the pooled risk of reoperation and mortality each above 14%. Preliminary data have suggested arthroplasty for minimally displaced fractures may lead to better patient outcomes, including improved ambulation, fewer reoperations, and a lower risk of death compared to internal fixation. While the preliminary data supporting the use of arthroplasty for minimally displaced fractures is promising, the necessary evidence to make this practice change remains lacking.

FASTER-HIP is a pragmatic, randomized, open-label, comparative effectiveness trial comparing hip arthroplasty versus internal fixation for minimally displaced femoral neck fractures. Randomization in this domain occurs in a 1:1 ratio (hip arthroplasty:internal fixation). The primary outcome is a composite of death within 120 days, ambulation status at 120 days, and days alive and out of hospital within 120 days of randomization. The primary outcome will be hierarchically assessed using the Win ratio. Secondary outcomes include the same composite at 365 days, individual components of the composite, health-related quality of life (EQ-5D-5L), and pain scores during hospitalization.

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Procedure: Hip arthroplasty

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Procedure: Internal fixation

Participants will undergo surgical treatment using standard hip arthroplasty techniques for femoral minimally displaced femoral neck fracture. A modern porous-coated press-fit or cemented hip arthroplasty prosthesis will be used at the treating surgeon's discretion. Press-fit implants that have no ingrowth or ongrowth surface will not be permitted. The type of hip prosthesis (hemiarthroplasty or total hip arthroplasty), bearing (single or dual mobility), or the method of arthroplasty fixation (cemented or uncemented) will be at the discretion of the treating surgeon.

Participants will undergo surgical treatment using standard fixation techniques for minimally displaced femoral neck fractures. The treating surgeon may perform fracture reduction maneuvers if desired. Fixed-angle devices and multiple screws will be permitted. The internal fixation device(s) will be inserted through a small lateral incision. Internal fixation constructs combining cancellous screws and fixed-angle devices will be permitted.

Plazo: 120 days after randomization

Death consists of time to all-cause mortality.

Ambulation will be evaluated using an ordinal ranking of independence.

Days alive and out of hospital will be calculated by subtracting the sum of days meeting one of two criteria below:

• Days not alive.
• Any day on which the participant had an overnight stay in a hospital, inpatient rehabilitation, skilled nursing facility, nursing home, inpatient mental health care facility, or long-term care facility.

Plazo: 365 days after randomization

Death consists of time to all-cause mortality.

Ambulation will be evaluated using an ordinal ranking of independence.

Days alive and out of hospital will be calculated by subtracting the sum of days meeting one of two criteria below:

• Days not alive.
• Any day on which the participant had an overnight stay in a hospital, inpatient rehabilitation, skilled nursing facility, nursing home, inpatient mental health care facility, or long-term care facility.

Plazo: 120 days post-randomization

Death consists of time to all-cause mortality.

Plazo: 12 months post-randomization

Death consists of time to all-cause mortality.

Plazo: 120 days post-randomization

Ambulation will be evaluated using an ordinal ranking of independence

Plazo: 12 months post-randomization

Ambulation will be evaluated using an ordinal ranking of independence

Plazo: 120 days post-randomization

Days alive and out of hospital will be calculated by subtracting the sum of days meeting one of two criteria below:

• Days not alive.
• Any day on which the participant had an overnight stay in a hospital, inpatient rehabilitation, skilled nursing facility, nursing home, inpatient mental health care facility, or long-term care facility.

Plazo: 12 months post-randomization

Days alive and out of hospital will be calculated by subtracting the sum of days meeting one of two criteria below:

• Days not alive.
• Any day on which the participant had an overnight stay in a hospital, inpatient rehabilitation, skilled nursing facility, nursing home, inpatient mental health care facility, or long-term care facility.

Plazo: 120 days days post-randomization

EQ-5D-5L - Range: 0 to 1, Higher scores indicates better self-perceived health

Plazo: 12 months post-randomization

EQ-5D-5L - Range: 0 to 1, Higher scores indicates better self-perceived health

Plazo: During hospitalization in the first seven postoperative days

The highest level of pain recorded daily in the participant's medical record - Range: 0-10, higher score indicates higher level of pain

Musculoskeletal Adaptive Platform Trial (MAPT): Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP)